Pharmaceuticals, Biopharmaceuticals, Nutraceuticals, Cosmetics and Medical Devices
Cleaning, Cleaning Validation, Acceptance Limit, Maximum Safe Carryover, MSC, Total Organic Carbon, TOC, Visual Residue Limit, VRL Visual Inspection, Process Capability, Statistical Process Control, SPC
This standard will be used to provide guidance on implementing the E3106-18 Standard Guide Science-Based and Risk-Based Cleaning Process Development and Validation and for the E3219 Standard Guide for Derivation of Health Based Exposure Limits (HBELs)
The title and scope are in draft form and are under development within this ASTM Committee.
Developed by Subcommittee: E55.03
Staff Manager: Travis Murdock
Date Initiated: 08-24-2018
Technical Contact: Andrew Walsh